ARDS, HumanALARMNCT04274296
Advisory Lead ARDS Respirator Management
An observational study of ARDS, Human, run by Mathias Maleczek at 1 site in Austria.
Trial summary
A advisory will be activated in the ICUs patient data management system. The trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Activation of Advisory
- Type of treatment
- Medical device
- How many people
- 472 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2020to 11 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at risk of ARDS at six intensive care units will be included in this trial. Study population will consist of medical and surgical ICU patients.
Who may be able to join
- LIPS >= 4, ventilated invasively at point of screening
Who cannot join
- ARDS at admission
- Pregnant patients
- Age < 18 years
- Patients with elevated intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
A advisory will be activated in the ICUs patient data management system. The trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the advisory group where advisories will be shown in the patient data management system.
To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)
Read the detailed description
Background Lung protective ventilation is a well-established treatment to reduce ventilator-induced lung injury (VILI) in patients suffering from ARDS. To quantify lung protective ventilation the concept of driving pressure (ΔP) and mechanical power were postulated.
Although low tidal volumes and low driving pressures are considered standard of care, it was shown that lung protective ventilation is very little used in ICU patients. Especially in those with a less severe lung disease.
Automated Clinical Decision Support (CDS) systems are gaining more attention in clinical practice. They have been successfully used to increase medical provider adherence to guidelines or local department policy. Another successful means of influencing behavior of medical providers are so called nudge-based interventions. Currently there is little evidence on nudge-type interventions or automated alerts for ventilator settings in the ICU. To our knowledge studies that linked these interventions to a change in patient's outcome are lacking.
Hypothesis Activation of an advisory in the patient data management system accompanied by educational sessions and feedback emails decrease ventilation driving pressure in mechanically ventilated patients at increased risk of ARDS (LIPS ≥ 4). As secondary outcome parameters, incidence of ARDS, ventilator free days, reintubation rate, length of stay in the ICU or the hospital and mortality at day 28 will be evaluated.
Methods As an advisory is activated in the ICU software, medical staff caring for the patients can't be blinded. Therefore, the trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the alert group where advisories will be shown in the patient data management system.
To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)
Outcome The primary outcome is an improvement of medical stuff's adherence to current recommendations shown by a reduction of the mean ventilator driving pressure (by using the AUC of driving pressures).
The secondary outcomes are ventilator free days, 28-day mortality, reintubation rate, incidence of ARDS and length of stay in the ICU and the hospital.
- Conditions
- ARDS, Human
- Being tested
- Activation of Advisory
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation of AdvisoryDevice
Advisory is activated which will show if driving pressure is greater or equal 15
| Study group | Role | What they receive |
|---|---|---|
| Control | Control-cohort in which no change in care is needed | |
| Advisory | Cohort in which advisory is activated Receives: Device: Activation of Advisory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of AUC of driving pressure
The driving pressure will be used to create a graph; The AUC will be calculated for each patient. Changes in AUC will be used as measurement for driving pressure over time.
Measured: 10 days
Secondary outcomes (5)
Change in ventilator free days
Measured: Day 1-28
28-day mortality, 90-day mortality and one-year mortality
Measured: 1 Year
Change in ARDS incidence
Measured: Day 1-28
Reintubation rate due to respiratory failure
Measured: Day 1-28
Reduction of mechanical power
Measured: Day 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Sep 2020
- Primary completion28 Mar 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathias Maleczek
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Austria GmbH, Medical University of Vienna
- Responsible party
- Sponsor-investigator, Mathias Maleczek, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274296
- Sponsor's protocol ID
- ALARM
- Acronym
- ALARM
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Burger-Klepp U, Maleczek M, Ristl R, Kroyer B, Raudner M, Krenn CG, Ullrich R. Using a clinical decision support system to reduce excess driving pressure: the ALARM trial. BMC Med. 2025 Jan 29;23(1):52. doi: 10.1186/s12916-025-03898-2.
PubMed 39875856
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advisory Lead ARDS Respirator Management
- ClinicalTrials.gov ID
- NCT04274296
- Acronym / sponsor ID
- ALARM / ALARM
- Conditions
- ARDS, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Mathias MaleczekUniversity, hospital or other
- Collaborators
- Philips Austria GmbH, Medical University of Vienna
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A advisory will be activated in the ICUs patient data management system. The trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the advisory group where advisories will be shown in the patient data management system.
To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)
Detailed description
Background Lung protective ventilation is a well-established treatment to reduce ventilator-induced lung injury (VILI) in patients suffering from ARDS. To quantify lung protective ventilation the concept of driving pressure (ΔP) and mechanical power were postulated.
Although low tidal volumes and low driving pressures are considered standard of care, it was shown that lung protective ventilation is very little used in ICU patients. Especially in those with a less severe lung disease.
Automated Clinical Decision Support (CDS) systems are gaining more attention in clinical practice. They have been successfully used to increase medical provider adherence to guidelines or local department policy. Another successful means of influencing behavior of medical providers are so called nudge-based interventions. Currently there is little evidence on nudge-type interventions or automated alerts for ventilator settings in the ICU. To our knowledge studies that linked these interventions to a change in patient's outcome are lacking.
Hypothesis Activation of an advisory in the patient data management system accompanied by educational sessions and feedback emails decrease ventilation driving pressure in mechanically ventilated patients at increased risk of ARDS (LIPS ≥ 4). As secondary outcome parameters, incidence of ARDS, ventilator free days, reintubation rate, length of stay in the ICU or the hospital and mortality at day 28 will be evaluated.
Methods As an advisory is activated in the ICU software, medical staff caring for the patients can't be blinded. Therefore, the trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the alert group where advisories will be shown in the patient data management system.
To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)
Outcome The primary outcome is an improvement of medical stuff's adherence to current recommendations shown by a reduction of the mean ventilator driving pressure (by using the AUC of driving pressures).
The secondary outcomes are ventilator free days, 28-day mortality, reintubation rate, incidence of ARDS and length of stay in the ICU and the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control-cohort in which no change in care is needed |
| Advisory | – | Device: Activation of AdvisoryCohort in which advisory is activated |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk of ARDS at six intensive care units will be included in this trial. Study population will consist of medical and surgical ICU patients.
Key inclusion criteria (1 listed)
- LIPS >= 4, ventilated invasively at point of screening
Key exclusion criteria (4 listed)
- ARDS at admission
- Pregnant patients
- Age < 18 years
- Patients with elevated intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation of AdvisoryAdvisory is activated which will show if driving pressure is greater or equal 15 | Device | Advisory |
Primary outcome
Change of AUC of driving pressure
Time frame: 10 days
The driving pressure will be used to create a graph; The AUC will be calculated for each patient. Changes in AUC will be used as measurement for driving pressure over time.
5 secondary outcomes
Change in ventilator free days
Time frame: Day 1-28
28-day mortality, 90-day mortality and one-year mortality
Time frame: 1 Year
Change in ARDS incidence
Time frame: Day 1-28
Reintubation rate due to respiratory failure
Time frame: Day 1-28
Reduction of mechanical power
Time frame: Day 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 39875856Burger-Klepp U, Maleczek M, Ristl R, Kroyer B, Raudner M, Krenn CG, Ullrich R. Using a clinical decision support system to reduce excess driving pressure: the ALARM trial. BMC Med. 2025 Jan 29;23(1):52. doi: 10.1186/s12916-025-03898-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human, run by Mathias Maleczek at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of AUC of driving pressure (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.